Coloplast Biatain STD Alginate 10x10cm
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Coloplast Biatain Std Alginate 10x10cm |
W000070556 |
3710 |
Issue
On 25th July AMS staff identified a defect on primary packaging pouches, during packaging, of minor missing patches of polyethylene. The defect could compromise the device's ability to maintain a sterile barrier. In addition, patches of burnt or cracked polyethylene have been identified on the inside face of the primary.
AMS is the contract manufacturer for the Coloplast branded labels.
Recall start date: October 14, 2024
Additional information
Details
| Coloplast A/S |
| Holtedam 1, Humlebaek, Denmark, 3050 |
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